Adventhealth Urology At Denver

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance, review of PT reports and laboratory staff interview, the laboratory failed to achieve satisfactory performance scores from the American Proficiency Institute in the specialty of Hematology for two out of three PT events in 2022 (events 1 and 3). See D2131 D2131 HEMATOLOGY CFR(s): 493.851(g) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance, review of PT reports and laboratory staff interview, the laboratory failed to achieve satisfactory performance scores of 80% or greater from the American Proficiency Institute in the specialty of Hematology for two out of three PT events in 2022 (events 1 and 3). Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 12.26.2022 revealed the API PT scores for the specialty of Hematology for the 2022 Event 1 was 73% and the 2022 Event 3 was 66%. 2. A review of the API PT results submitted to the laboratory was performed during the biennial recertification survey on February 7, 2022 by the State Agency. 3. Review of the API PT results submitted to the laboratory indicated unsatisfactory performance testing the analytes of Hematocrit (HCT) and Hemoglobin (HGB) for the 2022 Event 1 where a score of 60% was reported. 4. Review of the API PT results submitted to the laboratory indicated unsatisfactory performance testing the analyte of Protime (PT) for the 2022 Event 3 where a score of 0% was reported. 5. Review of the API PT results submitted to the laboratory did not indicate that unsuccessful performance was achieved in the specialty of Hematology. 6. The Technical Consultant stated during the onsite survey held on February 7, 2023 that they were aware of the unsatisfactory performance with the HCT, HGB and PT results for the two events, but were unaware that those scores resulted in unsuccessful participation for the specialty of Hematology. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assurance (QA) policy, Proficiency Testing (PT) results, Accuracy Verification (AV) documentation and staff interview, the laboratory failed to test at least twice annually urine bacteriology RT-PCR samples in 2022 as specified in their established QA policy. Findings: 1. The laboratory's QA policy states that urine bacteriology samples tested on the Bio Rad CFX96 instrument using an RT-PCR method will be sent to a reference lab at least twice annually to perform and document Accuracy Verification activities. 2. Review of both PT and AV records during the biennial recertification survey conducted on February 7, 2023 revealed that no samples were sent during 2022. 3. The Technical Supervisor verified on February 7, 2023 at 3:00 pm that no urine bacteriology samples were sent for Accuracy Verification during 2022 as specified in the laboratory's QA policy. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, personnel competency records, and staff interview, the laboratory failed to follow their policy to document all required components of competency when 3 of 3 testing personnel were assessed for the prothrombin time (PT) test and the automated semen analysis test in 2017. Findings include: a. The laboratory's policy for personnel competency states, "The procedures for evaluation of the competency of the staff must include, but are not limited to: direct observation of routine patient test performance, monitoring the recording and reporting of test results, review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records, direct observation of performance of instrument maintenance and function checks, assessment of test performance through testing internal and/or external proficiency testing samples, and assessment of problem solving skills." b. Records showed the competency assessments in 2017 of 3 of 3 testing personnel who perform prothrombin time testing on the Abbott i-STAT involved a written quiz, reading the test procedure, and an attestation, signed by the testing personnel and the technical consultant, stating, "I am able to demonstrate and understand 1) patient specimen collection, handling and identification, 2) testing procedure, 3) quality control, 4) reagent test pack and control handing and storage requirements, 5) documentation and result reporting procedures, and 5) (sic) trouble shooting error messages for the i-STAT system. c. Records showed the competency assessments in 2017 of 3 of 3 testing personnel who perform automated semen analysis using the SQA-V Gold Semen Analyzer involved a written quiz, reading the test procedure, viewing SQA-V videos, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- and an attestation, signed by the testing personnel and the technical consultant, stating, "I have read the SQA-V Analyzer procedure and viewed the MES-Global videos. I can perform daily and weekly maintenance procedures. I understand the importance of a properly filled capillary in order to obtain accurate results. I understand all reagent storage requirements and proper handling and use. I have performed Quality Control testing and understand how to troubleshoot and document failed QC testing. I can accurately perform patient testing along with documentation of results into the patient's EMR." d. Staff confirmed the evaluations did not contain all the components of competency assessment as required by federal CLIA regulation. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the lack of verification records, and staff interview, the laboratory failed in 2018 to verify before initial patient use on January 26, 2018, the manufacturer's stated performance specifications of the prothrombin time (PT) test using a replacement Abbott i-STAT portable clinical analyzer (serial #312253). Findings include: a. On 1-26-18, the laboratory began using a replacement i-STAT analyzer for PT testing of patient specimens. b. The laboratory's policy states, "Method performance will be verified (validated) by testing 1) accuracy, 2) precision, 3) reportable range of test results for the test system, and 4) verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. Documentation will be maintained for 2 years after test instrument and/or method is discontinued. TUCC will ensure that the test systems, equipment, instruments, reagents, materials and supplies function according to manufacturer's specification." c. No documentation existed that the laboratory verified that they could obtain on the replacement i-STAT analyzer, the analytical claims of the manufacturer. d. Staff stated they were unaware of this regulatory requirement for replacement analyzers and confirmed that the manufacturer's performance specifications had not been verified using this replacement test system before reporting patient results. D5781